Symlin Generic Name & Formulations
Legal Class
Rx
General Description
Pramlintide (as acetate) 1000mcg/mL; soln for SC inj; contains m-cresol, mannitol.
Pharmacological Class
Amylin analogue/amylinomimetic.
How Supplied
SymlinPen 60, 120—2 (multidose pen-injectors)
Manufacturer
Symlin Indications
Indications
Adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin and who have failed to achieve blood glucose control despite optimal insulin therapy.
Symlin Dosage and Administration
Adult
Do not mix with insulin. Reduce preprandial, short/rapid-acting insulin dose by 50% when starting pramlintide. Adjust insulin dose after target pramlintide dose is achieved and any nausea subsides. Give by SC inj into abdomen or thigh immediately before major meals (≥250 kcal or ≥30g carbohydrates); rotate inj sites (use different site for insulin). Type 1: initially 15mcg; titrate in 15mcg increments (max 60mcg) if no significant nausea occurs for ≥3 days. If nausea occurs at 45 or 60mcg dose, reduce to 30mcg; if not tolerated, consider discontinuing therapy. Type 2: initially 60mcg; may increase to 120mcg if no significant nausea occurs for ≥3 days; if nausea occurs at 120mcg reduce to 60mcg.
Children
Not established.
Symlin Contraindications
Contraindications
Gastroparesis. Hypoglycemia unawareness.
Symlin Boxed Warnings
Boxed Warning
Severe hypoglycemia.
Symlin Warnings/Precautions
Warnings/Precautions
Increased risk of severe hypoglycemia with insulin (esp. type 1 diabetics). Do not use in patients with poor compliance, HbA1c >9%, recurrent hypoglycemia needing assistance in the past 6 months, or if on prokinetic drugs. Discontinue if persistent severe nausea occurs. Visual or dexterity impairment. Monitor blood glucose frequently (pre- and post-meals, and at bedtime). Do not share pens between patients, even if the needle is changed. Hepatic impairment, ESRD: not studied. Pregnancy. Nursing mothers.
Symlin Pharmacokinetics
See Literature
Symlin Interactions
Interactions
Drugs that alter GI motility (eg, anticholinergics) and those that slow intestinal absorption (eg, α-glucosidase inhibitors): not recommended. May delay absorption of oral drugs (give these 1 hr before or 2 hrs after pramlintide). Increased risk of hypoglycemia with other antidiabetics (eg, sulfonylurea), ACEIs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, salicylates, somatostatin analogs, sulfonamide antibiotics; caution.
Symlin Adverse Reactions
Adverse Reactions
Nausea, vomiting, anorexia, headache, local allergy; insulin-dependent hypoglycemia.
Symlin Clinical Trials
See Literature
Symlin Note
Not Applicable
Symlin Patient Counseling
See Literature